BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 5636971 · Received May 6, 2016

    Report

    Report Number
    1319808-2016-00012
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    April 6, 2016
    Report Date
    May 6, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED FROM A VITROS TDM PV2 QUALITY CONTROL FLUID AFTER A CALIBRATION EVENT WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE FOR THIS EVENT. HISTORICAL QC DATA AND ACCEPTABLE WITHIN RUN PRECISION TESTING INDICATE THAT NEITHER THE VITROS VALP REAGENT OR THE VITROS 5600 INTEGRATED SYSTEM WERE CONTRIBUTORS TO THE EVENT. ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED AFTER RESTORING THE PREVIOUS VITROS VALP CALIBRATION, INDICATING A SUBOPTIMAL CALIBRATION AND IS LIKELY CONTRIBUTOR TO THE LOWER THAN EXPECTED VALP QUALITY CONTROL RESULTS. IMPROPER CALIBRATOR FLUID HANDLING OR REAGENT HANDLING CANNOT BE CONFIRMED OR EXCLUDED AS CONTRIBUTORS THAT RESULTED IN THE SUBOPTIMAL CALIBRATION. THE ASSIGNABLE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS AFTER PREFORMING A CALIBRATION EVENT WHEN USING NON-VITROS AND VITROS TDM CONTROLS ON A VITROS 5600 INTEGRATED SYSTEM. REAGENT LOT 2511-22-4730. TDM PV2 RESULTS OF 49.08, 48.50 AND 48.31 UG/ML VERSUS AN EXPECTED RESULT OF 61.4 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE OBTAINED OR REPORTED FROM THE LABORATORY, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293421 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-22-4730

    Patients

    Seq Age Sex Outcome Treatment
    1